Sites do not fill in their information in a consent form template; instead, consent forms will be created on behalf of sites based on the language they provide. That is, sites will provide their locally required language and consents will be created for the sites by the Coordinating Center, Lead Study Team, or sIRB.

videos for reviewing IRBs

capturing local considerations in IREx

Reviewing IRBs can use IREx to capture local considerations (aka local context) on a study-by-study basis.

One of the biggest challenges to relying on a single IRB (sIRB) is ensuring the Participating Site’s Human Research Protection Program (HRPP) is aware of the study, has completed the appropriate institutional reviews, and communicates all relevant local considerations to the sIRB.

Why should I use IREx to capture local considerations?

IREx offers to models for capturing local considerations, depending on how consent forms are generated:

Module 1 (Recommended): Participating sites enter their locally required language into the consent form themselves and then the HRPP uploads the local consents into the study-specific HRPP survey.

Module 2: Participating sites enter their locally required language into the HRPP and PI surveys. This information is then used by the coordinating center or lead study team to generate consent forms on behalf of each site.

Thus, the only difference between the two modules is what questions are asked on the HRPP and PI surveys. These PDFs include the questionnaires in each ‘module’. Note: In both modules, the HRPP is currently required to sign off on (validate) the PI survey.